Oak Ridge Products
FDA inspection history in McHenry, Illinois, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at McHenry, Illinois.
Cited most
Across all Oak Ridge Products observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
The complete Oak Ridge Products file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
McHenry, Illinois
One Form 483 · 2022 · 8 observations
Latest: Form 483, Sep 30, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-30 | 483 Form 483 | McHenry, Illinois | 8 | $99 |
Investigators on these documents
FEI number 1419823 · most recent document Sep 30, 2022
About Oak Ridge Products
How many FDA Form 483s has Oak Ridge Products received?
FDA Intel has 1 Form 483 on file for Oak Ridge Products; the most recent is dated Sep 30, 2022.
When was Oak Ridge Products last inspected by FDA?
The most recent FDA inspection document on file for Oak Ridge Products is a Form 483 dated Sep 30, 2022, for the site in McHenry, Illinois.
What did FDA cite at Oak Ridge Products?
The regulations cited most in the observations on file for Oak Ridge Products are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.